legislation/
regulation BY FRED PONTIUS
Tap Water Pharmaceuticals:
Back to the Future
Those who cannot remember the past are condemned
d to repeat it.
Philosopher George Santayanas (1905) often-quoted
of the importance of learning from the pastif we dont, past mistakes
S consumers spend billions of dollars on
U prescription drugs and personal care
products. In 2005 consumers spent $240
billion for prescription drugs, and pre-
scription drug use is rising among all ages. More
than half of all Americans take at least one pre-
scription drug; one in six take three or more pre-
scription drugs. After these drugs are ingested, the
amount that is not absorbed passes through the
body and ends up in wastewater and surface water.
Other personal care products (e.g., soap, sham-
poo) also make their way down the drain. Unfor-
tunately, these pharmaceuticals and personal care
products (PPCPs) are not completely degraded or
removed during wastewater treatment. In fact,
many PPCPs have been present in the environment
for as long as humans have been using them.
On Mar. 9, 2008, the Associated Press reported
on a five-month study in which drugs were
detected in the drinking water of 24 metropolitan
areas (Donn et al, 2008). Such reports of detect-
able levels of pharmaceuticals in drinking water
and the environment have caused a flurry of
media coverage, elevating concerns in the minds
of consumers, regulators, and politicians. So much
so that opportunistic politicians in this presiden-
tial election year, fueled by an alarmed populace,
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2008 American Water Works Association
uoted caution is a reminder
istakes are repeated.
will be tempted to pursuee legislative and regula-
re
tory proposals for PPCPs that would set th
back by more than 30 yearsa return
stone age of contaminant regulation.
ARE PPCPS REALLY EMERGING
the clock
retur to the
CONTAMINANTS?
An emerging contaminant is broadly defined
as any synthetic or naturally occurring chemical
or any microorganism that is not commonly
monitored in the environment but has the poten-
tial to enter the environment. These contaminants
may or may not have the potential to adversely
affect human health, the environment, or both.
PPCPs are commonly derived from municipal,
agricultural, and industrial wastewater sources
and pathways and have been detected in some
drinking waters and environmental waters at
low concentrations. Their occurrence, environ-
mental chemistry, human health significance,
and ecological effects are understood poorly, if
at all. Some pharmaceutical products such as
those used in animal agriculture enter a water
supply through agricultural runoff. Pharmaceu-
tical products, whether for animals or humans,
are administered at doses at which some amount
is excreted into wastewater.
legislation/
regulation

Wastewater treatment does not completely
remove or decompose PPCPs. Refractory com-
pounds remaining after wastewater treatment, also
called microconstituents, are discharged into lakes
and rivers and may enter downstream sources of
drinking water. Eventually microconstituents enter
sources of drinking water, which may include some
undegraded or partially degraded PPCP compounds,
and may enter a drinking water treatment plant.
Conventional drinking water treatment does not
completely remove or destroy these compounds.
Groundwater can also be contaminated by com-
pounds migrating through groundwater via septic
tank leach fields. These newly recognized contami-
nants represent a shift in traditional thinking,
because many are produced industrially yet dis-
persed to the environment from domestic, commer-
cial, and industrial uses.
The recent media coverage has presented PPCPs
in water as a new issue. However, PPCPs in the
environment have been the subject of study and
research since 1965. Research accelerated in the
1990s when analytical methods were developed
and/or improved. PPCPs comprise a diverse collec-
tion of thousands of chemical substances including
prescription and over-the-counter therapeutic drugs,
veterinary drugs, fragrances, and cosmetics, and
detecting them in water is not simple. That is why
advanced analytical instrumentation is required to
detect these emerging contaminants.
As analytical methods improve, emerging con-
taminants are being detected at lower and lower
concentrations. However, detection of a drinking
water contaminant does not mean that its presence
in drinking water is harmful to humans. In some
instances, contaminant exposure may have occurred
over a period of many years before detection, and it
may be many years after a contaminant is first
detected that the health significance of the contami-
nant is known. Although detectable, the health sig-
nificance of emerging contaminants is usually
unknown and may even be insignificant.

THE EMERGENCE
OF CHLOROFORM
The emergence of
PPCPs as a drinking
water issue parallels the
emergence of chloro-
form, a by-product of
chlorination that was
first regulated in 1979.
Chlorine was first used
as a drinking water dis-
infectant in the Jersey
City (N.J.) water supply
on Sept. 26, 1908. This
was the first time chlo-
rinated water was pro-
vided on a permanent
basis to US homes.
When chlorine is added
to water in the presence
of natural organic mat-
ter, by-products such as
chloroform are formed.
Consequently, use of
chlorine at Jersey City
likely resulted in the
first exposures to chlo-
roform and other disin-
fection by-products

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2008 American Water Works Association
legislation/
regulation
(DBPs) from drinking water, although analytical
methods for DBPs would not be developed until 70
years later.
By using chlorine as a disinfectant, the typhoid
fever death rate in Jersey City fell by more than 92%
between 1906 and 1926. Not surprisingly, chlorina-
tion of drinking water became a widespread practice
in the United States following its application at Jer-
sey City. The public health benefit of water chlorina-
tion and chlorine disinfection combined with filtra-
tion was clearly demonstrated, and chlorination is
standard water treatment practice today.
THMs, Organic Compounds, and PCPPs Arouse Pub-
lic Attention. In the 1970s, Johannes Rook (the
Netherlands) and Thomas Bellar (US Environmen-
tal Protection Agency [USEPA]), working indepen-
dently and in a similar timeframe on projects not
related to chloroform or DBPs, accidentally discov-
ered that chloroform, a type of trihalomethane
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2008 American Water Works Association
(THM), was created when drinking water was dis-
infected with chlorine. Typically, chloroform is the
THM that is most prevalent in drinking water.
Although unrelated, publicity surrounding
reports of the discovery of THMs coincided with
the finding of synthetic organic chemicals (SOCs)
in the New Orleans water supply. In 1972, a report
on the quality of the Mississippi River in Louisiana
was published. Sample sites included finished water
from the Carrollton water treatment plant in New
Orleans. Organic compounds from the water were
concentrated using granular activated carbon
(GAC), extracted from the GAC using a solvent
(chloroform), and identified. Thirty-six organic
compounds were isolated from the extracts col-
lected from finished water. Subsequent publicity
resulted in additional evaluation of drinking water
quality by the US General Accounting Office, with
results released in late 1973.
legislation/
regulation

Recent media coverage of PPCPs is similar to the
attention given to the discovery of THMs and detec-
tion of SOCs. For example, a three-part series in
Consumer Reports (Harris & Brecher, 1974) drew
attention to organic contaminants in New Orleans
drinking water. For historical perspective, the first
four paragraphs of part 1 of that series state:
New Orleans, like many other cities, gets its
drinking water from a heavily polluted sourcethe
Mississippi River. Many industries discharge their
wastes into the river, and many upriver cities dis-
charge their sewage into it. The rainwater runoff
from farmland carries a wide variety of pesticides,
herbicides, fertilizers, and other agricultural chemi-
cals that swell the Mississippis pollution burden.
Even on its better days, New Orleans drinking water
has an off-taste and off-odor. Its palatability trails
off further after large discharges or spillages of con-
taminants upriver.
Few New Orleans residents are alarmed. They have
been repeatedly assured by city officials that their water,
processed according to established water treatment
principles, meets the drinking water standards of the US
Public Health Service (PHS) and is safe. And so it
probably is, if one takes safe to mean that the water
wont cause typhoid, cholera, or other bacterial dis-
easesthe diseases that standard water treatment is
designed to prevent. But surely, as the senses of smell and
taste testify, some things remain in the treated water that
may not deserve a clean bill of health.
In 1969, the Federal Water Pollution Control
Administration sampled drinking water after it passed
through the New Orleans water treatment plant at
Carrollton, by far the largest in the city, delivering
more than 110 million gallons of water a day to
600,000 people. Tests were then run to identify
organic compounds in the samples. Thirty-six such
chemicals were identified; others were found but
could not be identified.
Three of the organic
chemicals (chloroform, ben-
zene, bis-chloroethyl ether)
were carcinogens, shown to
cause cancer in animal
experiments. Three others
were toxic, producing liver
damage in animals when
consumed even in small
quantities for long periods of
time. The long-term effects
of consuming small quanti-
ties of the other New Orleans
drinking water contami-
nants, identified and uniden-
tified, are unknown.

Additional studies of
the lower Mississippi River
by USEPA and of sur-
rounding areas by environ-
mental groups, as well as a
CBS prime time program
on Dec. 5, 1974, with Dan
Rather titled Caution,
Drinking Water May Be
D a n g e r o u s t o Yo u r
Health, drew further
public attention to drink-
ing water issues.

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legislation/
regulation
THE PRESSURE TO REGULATE
A US populace alarmed about the potential harm
from contaminants in drinking water has, without
exception, sought safety in the form of action from
government agencies and/or elected officials, regard-
less of whether the cause for alarm is real or imagi-
nary. The discovery of THMs and SOCs in drinking
water, in the absence of a national drinking water
law, coupled with concerns about potential but
unknown human health effects, provided fertile
ground for legislative action. The federal Safe Drink-
ing Water Act (SDWA)the first national legislation
intended to ensure safe drinking waterwas signed
into law on Dec. 16, 1974. Despite this regulation,
the true health significance of THMs and SOCs in
drinking water was not known, and questions still
remain about the health significance of low concen-
trations of SOCs and DBPs.
When the 1974 SDWA was first enacted, USEPA
had the general authority to regulate contaminants
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2008 American Water Works Association
of concern. For the most part, drinking water regu-
lations were based on the 1962 US Public Health
Service standards. Regulation of new contaminants
was very slow, and in 1986 Congress amended the
SDWA to require regulation of 83 contaminants
with specific deadlines for regulatory action, regard-
less of whether the contaminant was present or
even posed a human health risk.
The 1986 SDWA also required USEPA to regulate
25 new contaminants from a drinking water con-
taminant list every three years. Activists argued that
because the 83 contaminants might be detected in
some, although not all, drinking water supplies, they
posed a potential health threat and must be regu-
lated. Congress agreed. In addition, the 1986 SDWA
included requirements for filtration and disinfection
at surface water systems, and GAC was designated
as best available technology for treating SOCs.
To meet the mandate of regulating 83 contami-
nants and issuing other rules specified in the 1986
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SDWA amendments, USEPA issued new drinking
water regulations at a brisk pace from 1986 to
1993. Then regulatory activity essentially came to
a standstill. Why? It became very apparent that a
general requirement to regulate 25 contaminants
every three years just because they might occur in
drinking water was simply unrealistic. Such regula-
tions were to be issued regardless of whether the
contaminant actually occurred in drinking water.
Yet, the necessary technical information needed to
regulate new contaminants, especially regarding
human exposure, analytical detection, human
health effects, and treatment effectiveness, was
sorely lacking.
In addition, the agency was being forced by the
SDWA to direct its limited financial resources
toward development of regulations for contami-
nants that did not occur and that may never occur
nationally at concentrations of significance in drink-
ing water. By design, the national drinking water
program established by the SDWA is a partner-
shipUSEPA is to focus on contaminants of
national occurrence and national health concern,
and state primacy agencies are to address contami-
nants that are not regulated nationally by USEPA
but are of concern locally or statewide.
USEPA needed the flexibility to target its regula-
tory actions to those contaminants that posed a sig-
nificant national health risk. In 1996, Congress
amended the SDWA to give the agency the flexibility
it needed. USEPA has the authority to regulate a con-
taminant if all of the following conditions are met:
The contaminant may have an adverse effect
on the health of persons.
The contaminant is known to occur or there
is a substantial likelihood that the contaminant will
occur in public water systems with a frequency and
at levels of public health concern.
Regulation of the contaminant presents a
meaningful opportunity for health-risk reduction
for persons served by public water systems.
CCLs. USEPA is required to issue a contaminant
candidate list (CCL) every five years that lists
contaminants that are known or anticipated to
occur in public water systems and that may require
regulation. The SDWA requires that the agency
make regulatory determinations for at least five
contaminants from the most recent CCL every five
years. A regulatory determination is a formal deci-
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sion on whether USEPA should initiate a process
to develop a national primary drinking water reg-
ulation for a specific contaminant.
In July 2003, USEPA announced its final regula-
tory determinations for a subset of nine contami-
nants from the first CCL (CCL1). Sufficient health
and occurrence information was available to make
the determination to not regulate Acanthamoeba,
aldrin, dieldrin, hexachlorobutadiene, manganese,
metribuzin, naphthalene, sodium, and sulfate.
In May 2007, USEPA announced preliminary
determinations for 11 contaminants listed on the
second CCL (CCL2) and requested public com-
ment. Sufficient health and occurrence informa-
tion was available for the agency to make the
determination to not regulate boron; the dacthal
mono- and di-acid degradates; 1,1-dichloro-2,2-
bis(p-chlorophenyl)ethylene (DDE); 1,3-dichloro-
propene (Telone); 2,4-dinitrotoluene; 2,6-dinitro-
toluene; s-ethyl propylthiocarbamate (EPTC);
fonofos; terbacil; and 1,1,2,2-tetrachloroethane.
A final CCL2 regulatory determination is expected
in July 2008.
USEPAs determination to not regulate these
contaminants does not mean that the contaminants
will not be detected in some drinking waters. It
simply means that nationally there is no realistic
opportunity, by national regulation, to meaning-
fully reduce any adverse health risks that may be
posed by these contaminants. If a particular drink-
ing water system experienced a contamination
problem from any of these contaminants, the state
primacy agency would be responsible for solving
the contamination problem. Health effects informa-
tion for these contaminants, which is developed by
USEPA, is available to states to assist in making
public health assessments.
PHARMACEUTICALS CONSIDERED FOR CCL3
USEPA implemented a process for developing
the draft third CCL (CCL3), which differs from the
process used for CCL1 and CCL2. The new process
is based on recommendations from the National
Academy of Sciences National Research Council,
the National Drinking Water Advisory Council, and
other expert groups. The best available health effects
and occurrence data and information to evaluate
unregulated contaminants were considered. Potential
chemicals for listing were identified from the Super-
legislation/
regulation
fund program, registered pesticides, chemicals
detected in drinking water or source waters, chem-
icals released to the environment, and high-pro-
duction chemicals.
A multistep CCL process was used to screen
the universe of chemicals in order to identify
those with sufficient data to warrant further con-
sideration. A broad universe of 25,980 potential
chemicals (called the CCL pre-universe) was iden-
tified from 284 data sources. From this pre-uni-
verse, approximately 7,500 contaminants (called
the CCL universe) were screened based on the
availability of health and occurrence data for
initial consideration. Screening criteria were then
applied to the CCL universe to identify contami-
nants that should be further evaluated (the pre-
liminary CCL, or PCCL) based on a contami-
nants potential to occur in public water systems
and the potential for public health concern. Con-
taminants from the PCCL to be included on the
CCL were identified based on a more detailed
evaluation of occurrence and health effects data
and expert judgment. Public input was also sought
in October 2006 by requesting nominations of
contaminants to consider for the CCL. Nomi-
nated contaminants were incorporated into the
evaluation process. Expert panels were convened
to obtain review and input on the processes used
to develop the draft CCL and the CCL3.
The agency analyzed 287 pharmaceuticals for
possible inclusion on a draft list of contami-
nants. Most contaminants occurred at levels far
below concentrations currently associated with
any adverse health effects, based on the best
available human health effects data (Grumbles,
2008). One pharmaceutical, nitroglycerin, was
included on the CCL3. Nitroglycerin is used for
heart problems; however, the primary reason for
including it on the CCL3 is that it is widely used
to make explosives.
Senate Environment and Public Works Com-
mittee Chair Barbara Boxer (D-Calif.) argued
that USEPA failed to protect the public from
potentially dangerous exposure to pharmaceuti-
cals in drinking water. However, the best avail-
able science suggests something different. Regu-
lating PPCPs based on simple detection or a
directive of Congress would force a return to the
pre-1996SDWA era. The fact that more PPCPs
are being detected at very low (parts-per-trillion)
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is primarily the result of improved analytical
instrumentation. The fact that PPCPs can be
detected does not imply risk. To date, published
studies and reviews have concluded that no
potential health risks are associated with PPCPs
in water at the low levels detected. Other con-
taminant exposures may be much more signifi-
cant. For example, dietary exposure to hormones
such as the estrogen that naturally occurs in milk
and soy products is much higher than exposure
to residues of any estrogen-like pharmaceutical
in water.
At this time, available data indicate that a
meaningful risk reduction could not be achieved
to justify PPCP regulation under the SDWA. The
CCL process is iterative, repeated every five years,
and PPCP research is continuing. The fact that no
PPCPs may be included on the CCL3 does not
mean that these compounds will not be included
on future CCLs. PPCP compounds could indeed
be regulated in the future if the best available data
justify such a regulation.
Frederick W. Pontius is president of Pon-
tius Water Consultants Inc., 6657 W. Ottawa
Ave., Unit D-5, Littleton, CO 80218; e-mail:
fredp@pontiuswater.com. Pontius has a PhD in
civil (environmental) engineering, a masters
degree in environmental engineering, and a
bachelors degree in civil engineering from the
University of Colorado at Boulder. For more
than 30 years Pontius has worked in the areas
of regulatory compliance, water quality, and
water and wastewater treatment and is the
recipient of several AWWA Best Paper awards.
REFERENCES
Donn, J.; Mendoza, M.; & Pritchard, J., 2008. AP Probe Finds
Drugs in Drinking Water. Associated Press. http://
apnews.excite.com/article/20080309/D8VA1GG80.html,
(accessed Mar. 10, 2008).
Grumbles, B., 2008. Testimony before the Transportation,
Safety, Infrastructure Security and Water Quality Sub-
committee on the Environment and Public Works Com-
mittee, US Senate, April 15, 2008.
Harris, R.H. & Brecher, E.M., 1974. Is the Water Safe to Drink?
Part I: The Problem. Part II: How to Make it Safe. Part III:
What You Can Do. Consumer Reports, 436, 538, 623.
Santayana, G., 1905. The Life of Reason, Volume 1. Dodo
Press: Gloucester, U.K.